NCT Number: NCT07814079
The goal of this study is to map conducting channels within scar that cause ventricular tachycardia (VT) in patients with scar in their hearts in order to block these channels from causing VT with targeted radiofrequency ablation (cautery).
Participants undergoing VT ablation mapping of these channels by pacing many sites within the scar area and determining where these channels exit the scar into normal tissue. These exits will be ablated. Immediate success and success at 1 year will be evaluated.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Valhalla, New York, 10595, United States
Location status: Recruiting
Daniel Frenkel, MD
SUB_INVESTIGATOR
Jason Jacobson, MD
PRINCIPAL_INVESTIGATOR
Jason T Jacobson, MD
CONTACT
Sei Iwai, MD
CONTACT
Sei Iwai, MD
SUB_INVESTIGATOR
After standard VT induction and mapping procedures (noninvasive identification of induced VT exit sites with Vektor vMap; substrate mapping; initial pacemapping), the study will consist of pacing within the substrate and mapping all channel exits both noninvasively with vMap as well as invasively with high density mapping catheters within the heart by escape mapping (all paced sites creating a consistent paced morphology, up to the shortest stimulus-to-QRS interval achieved) as well as focal activation mapping of this channel exit while pacing within the channel. The noninvasive map will aid in focusing invasive mapping to a small area of the substrate. Once the exit sites are determined, ablation energy will be delivered based on the mapped exit sites in the substrate channel within 0.5cm of the exit with the goal of blocking each exit site mapped. After the ablation lesion set is delivered, repeat attempt to induce VT will be performed. If more VT is induced, additional ablation energy will be delivered guided by standard mapping techniques (substrate, slow conduction zones, pacemapping).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ablation will be guided by mapping the substrate "from the inside out" by identifying conducting channels as they might be activated during VT. Extensive pace mapping will be performed within scar areas identified during sinus rhythm mapping. The course of these channels will be identified and ablated across the distal portion, just proximal to the exit based on shortest stimulus-to-QRS interval obtained.
Time frame: Perioperative/Periprocedural: This will be measured at the end of the study ablation procedure only.
Inability to stimulate the ventricle (physiologic parameter) while pacing in the substrate area contained by the ablation lines through each pacemap exit, at sites that were able to stimulate the ventricle prior to ablation. This will be manifest by the absence of a QRS complex resultant from the pacing stimulus. This is a
Time frame: Perioperative/Periprocedural: This will be measured throughout the study ablation procedure.
Percent matching of VT exits determined by activation/entrainment/pace mapping for matched ECG morphologies with vMap determined exits
Time frame: Perioperative/Periprocedural: This will be measured throughout the study ablation procedure.
Percent matching of noninvasively mapped exit sites compared with invasively mapped channel exits
Time frame: Perioperative/Periprocedural: This will be measured during the study ablation procedure, after the first set of radiofrequency lesions is placed based in initial mapping.
VT inducibility after first lesion sets determined by channel mapping
Time frame: 1 year: This will be measured for each subject up to 1 year after the study procedure.
VT recurrence at 1 year determined by therapies delivered by implantable cardioverted defibrillator and presentation with sustained VT below ICD detection.
New York Medical College
Other
Segmental Substrate Isolation for the Treatment of Ventricular Tachycardia in Patients With Structural Heart Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07507539
Arrhythmias, Cardiac, Cardiac Conduction System Disease
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06703489
Arrhythmias, Cardiac, Cardiac Conduction System Disease
Boston, Massachusetts, United States
View Trial DetailsNCT07792694
Acute Myocardial Infarction (AMI), Arrhythmias, Cardiac
Eindhoven, North Brabant, Netherlands
View Trial DetailsNCT07777744
Arrhythmias, Cardiac, Cardiac Complexes, Premature
Chicago, Illinois, United States
View Trial Details